Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to the Election/Restriction response filed on 10/01/2025. Claims 1-10 and 16-26 are pending. Claims 1, 7, 16, and 23 are independent. Claims 1-6 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Invention II (claims 7-10 and 16-26 with claims 21-26 are newly added) and Species A (Figures 10A-10C) in the reply filed on 10/01/2025 is acknowledged.
Claim 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/01/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently, none of the claim limitations are being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the limitation "the vein" in each of lines 1 and 2 of the claim. Claim 10 depends on claim 7 which recites both “a first vein” an “a second vein.” It is unclear which of the veins that “the vein” in each of lines 1 and 2 claim 10 refers to. The art rejections for claim 10 will be reconsidered once the antecedent-basis issue is corrected. For the purpose of examination, the “the vein” is interpreted to be “one of the first or second vein” in line 1 of claim 10 and “the one of the first or second vein.”
The art rejection(s) below is/are made as best understood by the examiner because of the 35 USC 112 issue(s) stated above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Microsurgical spermatic-inferior epigastric vein anastomosis for treating nutcracker syndrome-associated varicocele in infertile men: a preliminary experience).
Regarding claims 16-18 and 21, Li discloses [claim 16] a method of treating a clinical urological problem, the method comprising: dissecting a first vein near the peritoneum (see title and page 95, both spermatic vein and the inferior epigastric vein are located near the peritoneum based on common anatomic knowledge. As shown in the figure and described on page 95, a veins is dissected or cut with a cut end for the end-to-end anastomosis); and anastomosing the first vein to a second vein (see title and page 95); [claim 17] wherein the first vein includes a spermatic vein (see title and page 95); [claim 18] wherein the second vein includes an inferior epigastric vein (see title and page 95); wherein the clinical urological problem is infertility (see title and page 95).
Claim(s) 23-26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vartanian (US Pub. No.: 2020/0114060).
Regarding claims 23-26, Vartanian discloses [claim 23] a method for forming a fluid connection between a first vessel (203, Fig. 2A-2I) and a second vessel (205, Figs. 2A-2I), the method comprising: advancing a first catheter (201, Figs. 2A-2B) into the first vessel, the first catheter defining a first aperture (distal opening of 201, Figs. 2A and 2B); advancing a second catheter (215, Figs. 2A and 2B) into the second vessel, the second catheter defining a second aperture (distal opening of 205, Figs. 2A and 2B); aligning the first aperture with the second aperture (Fig. 2B and Para. [0010]); forming a first opening in a wall of the first vessel proximate to the first aperture and a second opening in a wall of the second vessel proximate to the second aperture (Fig. 3C and Para. [0010]); extending a bridging device (guidewire 210; Fig. 2D; alternatively, combination of guidewire and balloon from the balloon catheter, Fig. 2D and Para. [0038]) through the first and second openings such that a portion of the bridging device is interposed between the first and second vessels (Fig. 2D); and deploying an implant (implant, Para. [0010] and Figs. 2F-2I) around the interposed portion of the bridging device to form a fluidic connection between the first and second vessels; [claim 24] wherein at least one of the first catheter or the second catheter includes a piercing element (208, Fig. 2C and Para. [0010]), the method further comprising: piercing, via the piercing element, the wall of the first vein and the wall of the second vein to form the first and second openings (Para. [0010]); [claim 25] wherein the bridging device includes a guidewire and a deployment element (guidewire 210 and balloon, Figs. 2D-2F and Paras. [0010] and [0038]), the method further comprising: advancing the deployment element over the guidewire (Figs. 2D-2E and Paras. [0010] and [0038]); and deploying the implant, via the deployment element, between the first and second vessels (Figs. 2F-2I and Para. [0010]); and [claim 26] wherein the deployment element includes a balloon (Para. [0038]), and deploying the implant including expanding the balloon from a collapsed configuration to an expanded configuration, the balloon deploying the implant in the expanded configuration (Para. [0038]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Li et al. (Microsurgical spermatic-inferior epigastric vein anastomosis for treating nutcracker syndrome-associated varicocele in infertile men: a preliminary experience) in view of Goren (Varicocele is the root cause of BPH: Destruction of the valves in the spermatic veins produces elevated pressure which diverts undiluted testosterone directly from the testes to the prostate)
Regarding claim 19, Li discloses the claimed invention of claim 16 as taught above. However, Li does not disclose that the clinical urological problem includes at least one of Benign Prostate hyperplasia (BPH), a lower urinary tract symptom (LUTS), or prostate cancer.
Goren teaches, in the same field of endeavor (clinical urological problem caused by varicocele), that varicocele is the root cause of a clinical urological problem, Benign Prostate hyperplasia BPH (see Title and Abstract).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of treating varicocele by anastomosing a first vein near the peritoneum to a second vein as disclosed by Li to be for treating Benign Prostate hyperplasia (BPH) in order to treat BPH caused by varicocele. Since varicocele is the root cause of BPH, the method of treating varicocele by anastomosing a first vein near the peritoneum to a second vein as disclosed by Li would also be obvious for treating BPH caused by varicocele.
Regarding claim 20, Li further discloses ligating the first vein (Fig. 1 and page 95).
Claim(s) 7-9, 16-18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Vartanian (US Pub. No.: 2020/0114060) in view of Belgrano et al. (Microsurgical spermaticoepigastric anastomosis for treatment of varicocele).
Regarding claims 7-9, Vartanian discloses [claim 7] a method, the method comprising: advancing a first catheter (201, Figs. 2A-2B) into a first vein (203, Figs. 2A and 2B and Paras. [0105] and [0068], venous-venous connection); advancing a second catheter (215, Figs. 2A and 2B) into a second vein (205, Paras. [0105] and [0068], venous-venous connection); aligning a first aperture of the first catheter with a second aperture of the second catheter (Fig. 2B and Para. [0010]); forming an opening in a wall of the first vein adjacent to the first aperture and an opening in a wall of the second vein adjacent to the second aperture (Fig. 2C and Para. [0010]); advancing a bridging device (guidewire 210, Fig. 2D and Para. [0010]) from the first catheter, through the openings, and into the second catheter such that a portion of the bridging device extends between the first and second veins; and deploying an implant (implant, Para. [0010] and Figs. 2F-2H) around the portion of the bridging device extending between the first and second veins. However, Vartanian does not specifically discloses that the method is for treating varicocele and associated conditions or any venous insufficiency; [claim 8] wherein the wherein the first vein is one of: a spermatic vein, or an ovarian vein; and [claim 9] wherein the second vein is one of: a deep circumflex vein, a femoral vein, iliac vein, or an epigastric vein.
Belgrano teaches, in the same field of endeavor (method of forming an anastomosis between two blood vessels), a method is for treating varicocele and associated conditions or any venous insufficiency comprising forming an anastomosis between a first vein and a second vein; wherein the first vein is a spermatic vein; wherein the second vein is an epigastric vein (see Abstract).
Before the effective filing date of the claimed invention, it would have been obvious to modify the method of Vartanian to be for treating varicocele and associated conditions or any venous insufficiency comprising forming an anastomosis between a first vein and a second vein; wherein the first vein is a spermatic vein; wherein the second vein is an epigastric vein as taught by Belgrano in order to create a new venous drainage to the testis to treat the patient with occlusion of the spermatic vein (Belgrano, Abstract).
Regarding claims 16-18 and 22, Vartanian discloses [claim 16] a method comprising: dissecting a first vein (203, Fig. 2C and Paras. [0010], [0105], [0049], and [0068], venous-venous connection; the first vein 203 is cut with a cutting element, such as a blade or a needle); and anastomosing the first vein to a second vein (205, Figs. 2A-2I, Paras. [0105] and [0068], venous-venous connection); [claim 22] wherein dissecting the first vein forms a first opening (Fig. 2C and Paras. [0010], [0105], and [0068]), the anastomosing the first vein to the second vein further comprising: advancing a first catheter (201, Figs. 2A-2B) defining a first aperture through the first vein such that the first aperture is substantially aligned with the first opening (Fig. 2C and Para. [0010]); advancing a second catheter (215, Figs. 2A and 2B) defining a second aperture through the second vein to substantially align the second aperture with the first aperture (Fig. 2C and Para. [0010]); forming a second opening in a wall of the second vein proximate to the second aperture (Fig. 2C and Para. [0010]); and communicating a bridging guidewire (guidewire 210, Fig. 2D) from the first aperture to the second aperture such that a portion of the bridging guidewire is interposed between the first and second veins (Fig. 2D), the interposed portion including an implant (implant, Para. [0010] and Figs 2F-2H) configured to fluidically couple the first and second veins. However, Vartanian does not specifically disclose that the method is for treating a clinical urological problem such that the first vein near the peritoneum; [claim 17] wherein the first vein includes a spermatic vein or an ovarian vein; [claim 18] wherein the second vein includes an inferior epigastric vein, a saphenous vein, a deep circumflex vein, a superior epigastric vein, an iliac vein, inferior vena cava, or a femoral vein.
Belgrano teaches, in the same field of endeavor (method of forming an anastomosis between two blood vessels), a method is for treating a clinical urological problem (see Abstract, varicocele) comprising forming an anastomosis between a first vein (spermatic vein is near the peritoneum based on common anatomic knowledge) which is near the peritoneum and a second vein (inferior epigastric vein); wherein the first vein is a spermatic vein; wherein the second vein is an inferior epigastric vein (see Abstract).
Before the effective filing date of the claimed invention, it would have been obvious to modify the method of Vartanian to be for treating a clinical urological problem (such as varicocele) comprising forming an anastomosis between a first vein which is near the peritoneum and a second vein; wherein the first vein is a spermatic vein; wherein the second vein is an inferior epigastric vein in order to create a new venous drainage to the testis to treat the patient with occlusion of the spermatic vein (Belgrano, Abstract).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Vartanian (US Pub. No.: 2020/0114060) in view of Belgrano et al. (Microsurgical spermaticoepigastric anastomosis for treatment of varicocele) as applied to claim 7 above, and further in view of Brenneman et al. (US Pub. No.: 2006/0111704).
Regarding claim 10, Vartanian in view of Belgrano disclose renders obvious of the claimed invention of claim 7 as taught above but fail to disclose activating an energy delivery element to ablate a portion of a wall of one of the first or second vein to cause closure of the one of the first or second vein.
Brenneman teaches, in the same field of endeavor (method of forming an anastomosis between two blood vessels), activating an energy delivery element (21 with 22’, Para. [0110] and Figs. 5D-5D) to ablate a portion of a wall of the vein/vessel to cause closure of a vein/vessel (Para. [0110]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the method of Vartanian in view of Belgrano to activating an energy delivery element to ablate a portion of a wall of a vein/vessel to cause closure of the vein/vessel as taught by Brenneman in order to obtain the advantage of assisting in allowing devices to pass through the vessel walls, as well as modifying the fistula to be created (Brenneman, Para. [0110]).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vartanian (US Pub. No.: 2020/0114060) in view of Belgrano et al. (Microsurgical spermaticoepigastric anastomosis for treatment of varicocele), and further in view of Goren (Varicocele is the root cause of BPH: Destruction of the valves in the spermatic veins produces elevated pressure which diverts undiluted testosterone directly from the testes to the prostate).
Regarding claim 19, Vartanian in view of Belgrano renders obvious of the claimed invention of claim 16 as taught above. Neither Vartanian nor Belgrano discloses that the clinical urological problem includes at least one of Benign Prostate hyperplasia (BPH), a lower urinary tract symptom (LUTS), or prostate cancer.
Goren teaches, in the same field of endeavor (clinical urological problem caused by varicocele), that varicocele is the root cause of BPH (see Title and Abstract).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of treating varicocele by anastomosing a first vein near the peritoneum to a second vein as disclosed by Vartanian in view of Belgrano to be for treating Benign Prostate hyperplasia (BPH) in order to treat BPH caused by varicocele. Since varicocele is the root cause of BPH, the method of treating varicocele by anastomosing a first vein near the peritoneum to a second vein as disclosed by Vartanian in view of Belgrano would also be obvious for treating BPH caused by varicocele.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Vartanian (US Pub. No.: 2020/0114060) in view of Belgrano et al. (Microsurgical spermaticoepigastric anastomosis for treatment of varicocele) and Goren (Varicocele is the root cause of BPH: Destruction of the valves in the spermatic veins produces elevated pressure which diverts undiluted testosterone directly from the testes to the prostate) as applied to claim 19 above, and further in view of Kobayashi et al. (US Pub. No.: 2021/0282390).
Regarding claim 20, Vartanian in view of Belgrano and Goren renders obvious of the claimed invention of claim 19 as taught above but fails to disclose ligating at least one the first vein or a third vein.
Kobayashi teaches, in the same field of endeavors (a method of connecting blood vessels), a method of forming an anastomosis between two blood vessels comprising temporarily ligating a first vessel/vein (Para. [0084] and [0034]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the method of Vartanian in view of Belgrano and Goren to include temporarily ligating the first vein as taught by Kobayashi to obtain the advantage of temporarily stopping the blood flow to the vein as needed for the surgery.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Vartanian (US Pub. No.: 2020/0114060) in view of Belgrano et al. (Microsurgical spermaticoepigastric anastomosis for treatment of varicocele), and further in view of Kantartzi (Male infertility and varicocele: myths and reality).
Regarding claim 21, Vartanian in view of Belgrano renders obvious of the claimed invention of claim 16 as taught above. Neither Vartanian nor Belgrano discloses that the clinical urological problem includes at least one of endometriosis, uterine fibroids, low testosterone, hypogonadism, alopecia, male pattern baldness, Nutcracker syndrome, or infertility.
Kantartzi teaches, in the same field of endeavor (a clinical urological problem caused by varicocele), that infertility is a clinical urological problem commonly caused by varicocele (see Abstract).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of treating varicocele by anastomosing a first vein near the peritoneum to a second vein as disclosed by Vartanian in view of Belgrano to be for treating infertility in order to treat infertility caused by varicocele. Since varicocele is a common cause of infertility, the method of treating varicocele by anastomosing a first vein near the peritoneum to a second vein as disclosed by Vartanian in view of Belgrano would also be obvious for treating infertility caused by varicocele.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20050080439 A1 Carson, Dean F. et al. discloses a method of anastomosing two blood vessels with alignment mechanisms.
US 20050277967 A1 Brenneman, Rodney et al. discloses a method of forming an anastomosis between two blood vessels.
US 20080161901 A1 Heuser; Richard R. et al. discloses a method of forming an anastomosis between two blood vessels.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771